Acronym

Study hypothesis

Early treatment with surfactant betters the outcome of respiratory distress syndrome (RDS). However, only about half of preterm infants less than 30 week-gestation need surfactant when supported by early nasal continuous positive airway pressure (CPAP) or mechanical ventilation. Therefore, there is a need for a rapid and easily accessible method to predict RDS. Lamellar body counts (LBC) on gastric aspirate using automatic blood cell counters have been shown to fulfil this condition.

Ethics approval

Research Ethics Committee of the Videnskabsetiske Committee for Bornhoms Regionskommune and Frederiksborg, Roskilde, Storstroms and Vestsjaelands Amter on 31/01/2006, (ref: Ø-2006-2-02G). All suction procedures for gastric aspirate were secure and tested. There were no serious adverse effects of Curosurf. All infants with RDS will receive Curosurf later as in our classical regiment and we have had very good results with this regiment.

Study design

Phase IV international multicenter randomised controlled study

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

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Condition

Respiratory distress syndrome (RDS) and gestational age less than 30 weeks

Gender

Target number of participants

Participant exclusion criteria

1. Prolonged rupture of the membranes >3 weeks2. Therapeutic infusions in the amniotic cave3. Lethal malformations4. Intubation in the delivery room or before randomisation5. Meconium or pus contamination of the gastric aspirate6. The neonatal ward too busy with other patients7. No gastric aspirate